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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MEDTRONIC IRELAND RESOLUTE INTEGRITY RX; STENT, CORONARY, DRUG-ELUTING
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MEDTRONIC IRELAND RESOLUTE INTEGRITY RX; STENT, CORONARY, DRUG-ELUTING Back to Search Results
Catalog Number RSINT35030UX
Medical Device Problem Code Device Expiration Issue (1216)
Health Effect - Clinical Code No Consequences Or Impact To Patient (2199)
Date of Event 04/10/2017
Type of Reportable Event Malfunction
Event or Problem Description
It was reported that a resolute integrity rx drug eluting stent was implanted in a patient to treat in-stent re-stenosis of a non-mdt stent.(everolimus) the resolute integrity stent was implanted 18 days post its expiry date.No patient injury reported.Patient is currently ok.
 
Additional Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
 
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Brand Name
RESOLUTE INTEGRITY RX
Common Device Name
STENT, CORONARY, DRUG-ELUTING
Manufacturer (Section D)
MEDTRONIC IRELAND
parkmore business park west
galway
MDR Report Key6559630
Report Number9612164-2017-00581
Device Sequence Number10922747
Product Code NIQ
UDI-Device Identifier00643169037274
UDI-Public00643169037274
Combination Product (Y/N)N
Initial Reporter StateAK
Initial Reporter CountryUS
PMA/510(K) Number
P110013
Number of Events Summarized1
Summary Report (Y/N)N
Device Implanted Year2017
Reporter Type Manufacturer
Report Source company representative,health
Initial Reporter Occupation Physician
Type of Report Initial,Followup
Report Date (Section B) 04/13/2017
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Operator of Device Health Professional
Device Expiration Date03/23/2017
Device Catalogue NumberRSINT35030UX
Device Lot Number0007514372
Was Device Available for Evaluation? No
Initial Date Received by Manufacturer 04/13/2017
Supplement Date Received by Manufacturer04/13/2017
Initial Report FDA Received Date05/11/2017
Supplement Report FDA Received Date10/03/2017
Is This a Single-Use Device that was
Reprocessed and Reused on a Patient? (Y/N)		 No
Patient Sequence Number1
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